C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection

• Status: Completed
• Trial end date: 2018-10-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single arm trial in which patient who have ongoing antibody mediated rejection of a kidney transplant deemed refractory to maximal medical therapy are given the complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing antibody mediated injury. A maximum of 5 patients will be enrolled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bonnie Lonze; NYU Langone Health
• Collaborator: CSL Behring
• Treatments: Antibodies; Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein

Criteria

Inclusion Criteria:

• Kidney transplant with acute antibody mediated rejection refractory to standard therapy

Exclusion Criteria:

• Patients with known intolerance of or anaphylaxis to Berinert